Xyrem For A Child?

On the Xyrem website, I read that it has not been approved for children. How many have children that are taking this, and do you feel that the benefits out weigh the side effects? I am trying to figure out if we should talk to his doctor about Xyrem or not. We have only tried Ritalin and Paxil and have not raised his dose yet, although they are not helping him much.

Reading what some adults have said about it, how it changed their life, it makes me wonder if we should look into this. Any thoughts would be appreciated!

It's not illegal (at least not in Australia) for children to be given medicines that are not approved for children. Doctors can prescribe them "off-label". I think it would be important though, that the particular doctor was familiar with using the particular medicine in children. This commonly happens with medications used in children, as there often isn't enough children with the condition for a clinical trial and/or the market for the drug company to do the extra work(and cost) needed to get the approval for children.

I thought it would be illegal to but it turns out it isn't illegal to prescribe it. I talked with my sister, who is a nurse, and she said it is more like a warning to the doctors that it hasn't been approved. They can still prescribe it though. I have seen a few threads with people who are using Xyrem with their children and was just kind of wondering how harsh the side effects are. I don't know if my doctor even knows about Xyrem so I could possible have to switch doctors for it.

If this drug is not yet approve, then this is harmful for children much better if this drug is undergo first in a clinical trial and much better if it gets a positive output and medical researchers should also study and reduce its side effects.

If this drug is not yet approve, then this is harmful for children much better if this drug is undergo first in a clinical trial and much better if it gets a positive output and medical researchers should also study and reduce its side effects.

A drug can always be prescribed "off label" when the benefits outweigh the risk.

In order for a drug to be licensed, it has to be tested on people in different age groups- generally 2-18 years and 18 and over.

It is a lengthy and very expensive process to run clinical trials and pursue licensure for an age group.

Since there are only about 50,000 diagnosed Narcoleptics, and most of us are diagnosed over the age of 18, the number of Narcoleptics under 18 is small.

So, it would not be cost-effective to pursue licensure for such a small patient population. That is the reason for the "Orphan Drug" program through which Xyrem was licensed in the first place. Treatments for "Rare Diseases" are not cost effective to research, so the government started a program to do just that.

When a drug is not licensed for under 18, it does not mean that it is not safe or effective and cannot be used. It simply has not been studied in order to gain licensure.